drugset / Trial / NCT03621670
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).
Timeline
- Start
- 2018-07-27
- Primary completion
- 2024-12-27
- Completion
- 2024-12-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bexsero | Vaccine | — | Intramuscular |
| Background | HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN | Vaccine | — | Intramuscular |
| Background | M-M-R II | Vaccine | — | Intramuscular |
| Background | PCV20 | Vaccine | — | Intramuscular |
| Background | Pediarix | Vaccine | — | Intramuscular |
| Background | Prevnar 13 | Vaccine | — | Intramuscular |
| Background | Rotarix | Vaccine | — | Intramuscular |
| Background | Varivax | Vaccine | — | Intramuscular |